History of Xarelto
The U.S. Food and Drug Administration approved the anticoagulant medication Xarelto in 2011 to help patients who were at risk of a stroke because of atrial fibrillation (abnormal heart rhythm). The FDA also allowed for the use of the drug to help reduce the risks of deep vein thrombosis and pulmonary embolism following knee or hip replacement surgery.
In 2013, the FDA required that Janssen Pharmaceuticals, Inc., the makers of Xarelto, include a black box warning that warned patients against premature discontinuation of the the drug, as it increased the risk of thrombotic events and spinal/epidural hematoma.
In 2014, the FDA once again required that Xarelto include a warning, but this time about the drug causing unstoppable internal bleeding. The warning was to be specific in stating that no antidote existed for Xarelto.
In 2014, Xarelto manufacturers Bayer and Johnson & Johnson, sought to expand the use of the drug to prevent heart attacks and strokes. The FDA denied the request on the basis that clinical data did not support the claims.
In August 2016, the FDA rejected a possible antidote for Xarelto’s adverse effects of uncontrolled bleeding.